[Federal Register Volume 82, Number 22 (Friday, February 3, 2017)]
[Rules and Regulations]
[Pages 9174-9189]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-02300]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
45 CFR Part 102
RIN 0991-AC0
Annual Civil Monetary Penalties Inflation Adjustment
AGENCY: Department of Health and Human Services, Office of the
Assistant Secretary for Financial Resources.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Department of Health and Human Services (HHS) is updating
its regulations to reflect required annual inflation-related increases
to the civil monetary penalties in its regulations, pursuant to the
Federal Civil Penalties Inflation Adjustment Act Improvement Act of
2015.
DATES: This rule is effective February 3, 2017.
FOR FURTHER INFORMATION CONTACT: Andrea Brandon, Deputy Assistant
Secretary for Grants and Acquisitions, Office of the Assistant
Secretary for Financial Resources, Room 514-G, Hubert Humphrey
Building, 200 Independence Avenue SW., Washington DC 20201; 202-690-
6396; FAX 202-690-5405.
SUPPLEMENTARY INFORMATION:
I. Background
The Federal Civil Penalties Inflation Adjustment Act Improvements
Act of 2015 (Sec. 701 of Pub. L. 114-74) (the ``Act''), which is
intended to improve the effectiveness of civil monetary penalties
(``CMPs'') and to maintain the deterrent effect of such penalties,
requires agencies to adjust the civil monetary penalties for inflation
annually.
The Department of Health and Human Services (HHS) lists the civil
monetary penalties and the penalty amounts administered by all of its
agencies in tabular form in 45 CFR 102.3.
II. Calculation of Adjustment
The annual inflation adjustment for each applicable civil monetary
penalty is determined using the percent increase in the Consumer Price
Index for all Urban Consumers (CPI-U) for the month of October of the
year in which the amount of each civil penalty was most recently
established or modified. In the December 16, 2016, OMB Memorandum for
the Heads of Executive Agencies and Departments, M-17-11,
Implementation of the 2017 annual adjustment pursuant to the Federal
Civil Penalties Inflation Adjustment Act Improvements Act of 2015, OMB
published the multiplier for the required annual adjustment. The cost-
of-living adjustment multiplier for 2017, based on the CPI-U for the
month of October 2016, not seasonally adjusted, is 1.01636.
Using the 2017 multiplier, HHS adjusted all its applicable monetary
penalties in 45 CFR 102.3.
III. Statutory and Executive Order Reviews
The 2015 Act Requires Federal Agencies To Publish Annual Penalty
Inflation Adjustments Notwithstanding Section 553 of the Administrative
Procedure Act
A. Executive Order 12866: Regulatory Planning and Review and Executive
Order 13563: Improving Regulation and Regulatory Review
Section 4 of the 2015 Act directs federal agencies to publish
annual adjustments no later than January 15, 2017. In accordance with
section 553 of the Administrative Procedure Act (APA), most rules are
subject to notice and comment and are effective no earlier than 30 days
after publication in the Federal Register. However, Section 4(b)(2) of
the 2015 Act provides that each agency shall make the annual inflation
adjustments ``notwithstanding section 553'' of the APA. According to
OMB's Memorandum M-17-11, Memorandum of the Heads of Executive
Departments and Agencies (December 16, 2016) the phrase
``notwithstanding section 553'' means that ``the public procedure the
APA generally provides--notice, an opportunity for comment, and a delay
in effective date--is not required for agencies to issue regulations
implementing the annual adjustment.'' Consistent with the language of
the 2015 Act and OMB's implementation guidance, this rule is not
subject to notice and an opportunity for public comment and will be
effective immediately upon publication.
B. Review Under Procedural Statutes and Executive Orders
Pursuant to OMB Memorandum for the Heads of Executive Departments
and Agencies, M-17-11, HHS has determined that making technical changes
to the amount of civil monetary penalties in its regulations does not
trigger any requirements under procedural statutes and Executive Orders
that govern rulemaking procedures.
IV. Effective Date
This rule is effective February 3, 2017. The adjusted civil penalty
amounts apply to civil penalties assessed on or after February 3, 2017,
when the
[[Page 9175]]
violation occurred after November 2, 2015. If the violation occurred
prior to November 2, 2015, or a penalty was assessed prior to September
6, 2016, the pre-adjustment civil penalty amounts in effect prior to
September 6, 2016 will apply.
List of Subjects in 45 CFR Part 102
Administrative practice and procedure, Penalties.
For reasons discussed in the preamble, the Department of Health and
Human Services amends subtitle A, title 45 of the Code of Federal
Regulations as follows:
PART 102--ADJUSTMENT OF CIVIL MONETARY PENALTIES FOR INFLATION
0
1. The authority citation for part 102 continues to read as follows:
Authority: Public Law 101-410, Sec. 701 of Public Law 114-74,
31 U.S.C. 3801-3812.
0
2. Amend Sec. 102.3 by revising the table to read as follows:
Sec. 102.3 Penalty adjustment and table.
* * * * *
Civil Monetary Penalty Authorities Administered by HHS Agencies and Penalty Amounts
[Effective February 3, 2017]
--------------------------------------------------------------------------------------------------------------------------------------------------------
Citation Date of
------------------------------------------------------------------- last 2016 2017
penalty Maximum Maximum
HHS agency Description \2\ figure or adjusted adjusted
U.S.C. CFR \1\ adjustment penalty ($) penalty ($)
\3\ \4\
--------------------------------------------------------------------------------------------------------------------------------------------------------
21 U.S.C.:
333(b)(2)(A)......................... ....................... FDA............. Penalty for violations 2016 98,935 100,554
related to drug samples
resulting in a conviction
of any representative of
manufacturer or
distributor in any 10-year
period.
333(b)(2)(B)......................... ....................... FDA............. Penalty for violation 2016 1,978,690 2,011,061
related to drug samples
resulting in a conviction
of any representative of
manufacturer or
distributor after the
second conviction in any
10-yr period.
333(b)(3)............................ ....................... FDA............. Penalty for failure to make 2016 197,869 201,106
a report required by 21
U.S.C. 353(d)(3)(E)
relating to drug samples.
333(f)(1)(A)......................... ....................... FDA............. Penalty for any person who 2016 26,723 27,160
violates a requirement
related to devices for
each such violation.
Penalty for aggregate of 2016 1,781,560 1,810,706
all violations related to
devices in a single
proceeding.
333(f)(2)(A)......................... ....................... FDA............. Penalty for any individual 2016 75,123 76,352
who introduces or delivers
for introduction into
interstate commerce food
that is adulterated per 21
U.S.C. 342(a)(2)(B) or any
individual who does not
comply with a recall order
under 21 U.S.C. 350l.
Penalty in the case of any 2016 375,613 381,758
other person other than an
individual) for such
introduction or delivery
of adulterated food.
Penalty for aggregate of 2016 751,225 763,515
all such violations
related to adulterated
food adjudicated in a
single proceeding.
333(f)(3)(A)......................... ....................... FDA............. Penalty for all violations 2016 11,383 11,569
adjudicated in a single
proceeding for any person
who violates 21 U.S.C.
331(jj)(1) by failing to
submit the certification
required by 42 U.S.C.
282(j)(5)(B) or knowingly
submitting a false
certification; by failing
to submit clinical trial
information under 42
U.S.C. 282(j); or by
submitting clinical trial
information under 42
U.S.C. 282(j) that is
false or misleading in any
particular under 42 U.S.C.
282(j)(5)(D).
333(f)(3)(B)......................... ....................... FDA............. Penalty for each day any 2016 11,383 11,569
above violation is not
corrected after a 30-day
period following
notification until the
violation is corrected.
333(f)(4)(A)(i)...................... ....................... FDA............. Penalty for any responsible 2016 284,583 289,239
person that violates a
requirement of 21 U.S.C.
355(o) (post-marketing
studies, clinical trials,
labeling), 21 U.S.C.
355(p) (risk evaluation
and mitigation (REMS)), or
21 U.S.C. 355-1 (REMS).
Penalty for aggregate of 2016 1,138,330 1,156,953
all such above violations
in a single proceeding.
333(f)(4)(A)(ii)..................... ....................... FDA............. Penalty for REMS violation 2016 284,583 289,239
that continues after
written notice to the
responsible person for the
first 30-day period (or
any portion thereof) the
responsible person
continues to be in
violation.
Penalty for REMS violation 2016 1,138,330 1,156,953
that continues after
written notice to
responsible person doubles
for every 30-day period
thereafter the violation
continues, but may not
exceed penalty amount for
any 30-day period.
Penalty for aggregate of 2016 11,383,300 11,569,531
all such above violations
adjudicated in a single
proceeding.
333(f)(9)(A)......................... ....................... FDA............. Penalty for any person who 2016 16,503 16,773
violates a requirement
which relates to tobacco
products for each such
violation.
[[Page 9176]]
Penalty for aggregate of 2016 1,100,200 1,118,199
all such violations of
tobacco product
requirement adjudicated in
a single proceeding.
333(f)(9)(B)(i)(I)................... ....................... FDA............. Penalty per violation 2016 275,050 279,550
related to violations of
tobacco requirements.
Penalty for aggregate of 2016 1,100,200 1,118,199
all such violations of
tobacco product
requirements adjudicated
in a single proceeding.
333(f)(9)(B)(i)(II).................. ....................... FDA............. Penalty in the case of a 2016 275,050 279,550
violation of tobacco
product requirements that
continues after written
notice to such person, for
the first 30-day period
(or any portion thereof)
the person continues to be
in violation.
Penalty for violation of 2016 1,100,200 1,118,199
tobacco product
requirements that
continues after written
notice to such person
shall double for every 30-
day period thereafter the
violation continues, but
may not exceed penalty
amount for any 30-day
period.
Penalty for aggregate of 2016 11,002,000 11,181,993
all such violations
related to tobacco product
requirements adjudicated
in a single proceeding.
333(f)(9)(B)(ii)(I).................. ....................... FDA............. Penalty for any person who 2016 275,050 279,550
either does not conduct
post-market surveillance
and studies to determine
impact of a modified risk
tobacco product for which
the HHS Secretary has
provided them an order to
sell, or who does not
submit a protocol to the
HHS Secretary after being
notified of a requirement
to conduct post-market
surveillance of such
tobacco products.
Penalty for aggregate of 2016 1,100,200 1,118,199
for all such above
violations adjudicated in
a single proceeding.
333(f)(9)(B)(ii)(II)................. ....................... FDA............. Penalty for violation of 2016 275,050 279,550
modified risk tobacco
product post-market
surveillance that
continues after written
notice to such person for
the first 30-day period
(or any portion thereof)
that the person continues
to be in violation.
Penalty for post-notice 2016 1,100,200 1,118,199
violation of modified risk
tobacco product post-
market surveillance shall
double for every 30-day
period thereafter that the
tobacco product
requirement violation
continues for any 30-day
period, but may not exceed
penalty amount for any 30-
day period.
Penalty for aggregate above 2016 11,002,000 11,181,993
tobacco product
requirement violations
adjudicated in a single
proceeding.
333(g)(1)............................ ....................... FDA............. Penalty for any person who 2016 284,583 289,239
disseminates or causes
another party to
disseminate a direct-to-
consumer advertisement
that is false or
misleading for the first
such violation in any 3-
year period.
Penalty for each subsequent 2016 569,165 578,477
above violation in any 3-
year period.
333 note............................. ....................... FDA............. Penalty to be applied for 2016 275 279
violations of restrictions
on the sale or
distribution of tobacco
products promulgated under
21 U.S.C. 387f(d) (e.g.,
violations of regulations
in 21 CFR part 1140) with
respect to a retailer with
an approved training
program in the case of a
second regulation
violation within a 12-
month period.
Penalty in the case of a 2016 550 559
third tobacco product
regulation violation
within a 24-month period.
Penalty in the case of a 2016 2,200 2,236
fourth tobacco product
regulation violation
within a 24-month period.
Penalty in the case of a 2016 5,501 5,591
fifth tobacco product
regulation violation
within a 36-month period.
Penalty in the case of a 2016 11,002 11,182
sixth or subsequent
tobacco product regulation
violation within a 48-
month period as determined
on a case-by-case basis.
[[Page 9177]]
Penalty to be applied for 2016 275 279
violations of restrictions
on the sale or
distribution of tobacco
products promulgated under
21 U.S.C. 387f(d) (e.g.,
violations of regulations
in 21 CFR part 1140) with
respect to a retailer that
does not have an approved
training program in the
case of the first
regulation violation.
Penalty in the case of a 2016 550 559
second tobacco product
regulation violation
within a 12-month period.
Penalty in the case of a 2016 1,100 1,118
third tobacco product
regulation violation
within a 24-month period.
Penalty in the case of a 2016 2,200 2,236
fourth tobacco product
regulation violation
within a 24-month period.
Penalty in the case of a 2016 5,501 5,591
fifth tobacco product
regulation violation
within a 36-month period.
Penalty in the case of a 2016 11,002 11,182
sixth or subsequent
tobacco product regulation
violation within a 48-
month period as determined
on a case-by-case basis.
335b(a).............................. ....................... FDA............. Penalty for each violation 2016 419,320 426,180
for any individual who
made a false statement or
misrepresentation of a
material fact, bribed,
destroyed, altered,
removed, or secreted, or
procured the destruction,
alteration, removal, or
secretion of, any material
document, failed to
disclose a material fact,
obstructed an
investigation, employed a
consultant who was
debarred, debarred
individual provided
consultant services.
Penalty in the case of any 2016 1,677,280 1,704,720
other person (other than
an individual) per above
violation.
360pp(b)(1).......................... ....................... FDA............. Penalty for any person who 2016 2,750 2,795
violates any such
requirements for
electronic products, with
each unlawful act or
omission constituting a
separate violation.
Penalty imposed for any 2016 937,500 952,838
related series of
violations of requirements
relating to electronic
products.
42 U.S.C.
262(d)............................... ....................... FDA............. Penalty per day for 2016 215,628 219,156
violation of order of
recall of biological
product presenting
imminent or substantial
hazard.
263b(h)(3)........................... ....................... FDA............. Penalty for failure to 2016 16,773 17,047
obtain a mammography
certificate as required.
300aa-28(b)(1)....................... ....................... FDA............. Penalty per occurrence for 2016 215,628 219,156
any vaccine manufacturer
that intentionally
destroys, alters,
falsifies, or conceals any
record or report required.
256b(d)(1)(B)(vi).................... ....................... HRSA............ Penalty for each instance 2016 5,437 5,526
of overcharging a 340B
covered entity.
299c-(3)(d).......................... ....................... AHRQ............ Penalty for an 2016 14,140 14,371
establishment or person
supplying information
obtained in the course of
activities for any purpose
other than the purpose for
which it was supplied.
653(l)(2)............................ 45 CFR 303.21(f)....... ACF............. Penalty for Misuse of 2016 1,450 1,474
Information in the
National Directory of New
Hires.
262a(i)(1)........................... 42 CFR 1003.910........ OIG............. Penalty for each individual 2016 327,962 333,327
who violates safety and
security procedures
related to handling
dangerous biological
agents and toxins.
Penalty for any other 2016 655,925 666,656
person who violates safety
and security procedures
related to handling
dangerous biological
agents and toxins.
300jj-51............................. ....................... OIG............. Penalty per violation for 2016 1,000,000 1,016,360
committing information
blocking.
1320a-7a(a).......................... 42 CFR 1003.210(a)(1).. OIG............. Penalty for knowingly 2016 15,024 15,270
presenting or causing to
be presented to an
officer, employee, or
agent of the United States
a false claim.
Penalty for knowingly 2016 15,024 15,270
presenting or causing to
be presented a request for
payment which violates the
terms of an assignment,
agreement, or PPS
agreement.
42 CFR 1003.210(a)(2) ................ Penalty for knowingly 2016 22,537 22,906
giving or causing to be
presented to a
participating provider or
supplier false or
misleading information
that could reasonably be
expected to influence a
discharge decision.
42 CFR 1003.210(a)(3) ................ Penalty for an excluded 2016 15,024 15,270
party retaining ownership
or control interest in a
participating entity.
[[Page 9178]]
42 CFR 1003.1010 ................ Penalty for remuneration 2016 15,024 15,270
offered to induce program
beneficiaries to use
particular providers,
practitioners, or
suppliers.
42 CFR 1003.210(a)(4) ................ Penalty for employing or 2016 14,718 14,959
contracting with an
excluded individual.
42 CFR 1003.310(a)(3) ................ Penalty for knowing and 2016 73,588 74,792
willful solicitation,
receipt, offer, or payment
of remuneration for
referring an individual
for a service or for
purchasing, leasing, or
ordering an item to be
paid for by a Federal
health care program.
42 CFR 1003.210(a)(1) Penalty for ordering or 2016 10,874 11,052
prescribing medical or
other item or service
during a period in which
the person was excluded.
42 CFR 1003.210(a)(6) Penalty for knowingly 2016 54,372 55,262
making or causing to be
made a false statement,
omission or
misrepresentation of a
material fact in any
application, bid, or
contract to participate or
enroll as a provider or
supplier.
42 CFR 1003.210(a)(8) ................ Penalty for knowing of an 2016 10,874 11,052
overpayment and failing to
report and return.
42 CFR 1003.210(a)(7) ................ Penalty for making or using 2016 54,372 55,262
a false record or
statement that is material
to a false or fraudulent
claim.
42 CFR 1003.210(a)(9) ................ Penalty for failure to 2016 16,312 16,579
grant timely access to HHS
OIG for audits,
investigations,
evaluations, and other
statutory functions of HHS
OIG.
1320a-7a(b).......................... ....................... OIG............. Penalty for payments by a 2016 4,313 4,384
hospital or critical
access hospital to induce
a physician to reduce or
limit services to
individuals under direct
care of physician or who
are entitled to certain
medical assistance
benefits.
Penalty for physicians who 2016 4,313 4,384
knowingly receive payments
from a hospital or
critical access hospital
to induce such physician
to reduce or limit
services to individuals
under direct care of
physician or who are
entitled to certain
medical assistance
benefits.
42 CFR 1003.210(a)(10) Penalty for a physician who 2016 7,512 7,635
executes a document that
falsely certifies home
health needs for Medicare
beneficiaries.
1320a-7e(b)(6)(A).................... 42 CFR 1003.810........ OIG............. Penalty for failure to 2016 36,794 37,396
report any final adverse
action taken against a
health care provider,
supplier, or practitioner.
1320b-10(b)(1)....................... 42 CFR 1003.610(a)..... OIG............. Penalty for the misuse of 2016 9,893 10,055
words, symbols, or emblems
in communications in a
manner in which a person
could falsely construe
that such item is
approved, endorsed, or
authorized by HHS.
1320b-10(b)(2)....................... 42 CFR 1003.610(a)..... OIG............. Penalty for the misuse of 2016 49,467 50,276
words, symbols, or emblems
in a broadcast or telecast
in a manner in which a
person could falsely
construe that such item is
approved, endorsed, or
authorized by HHS.
1395i-3(b)(3)(B)(ii)(1).............. 42 CFR 1003.210(a)(11). OIG............. Penalty for certification 2016 2,063 2,097
of a false statement in
assessment of functional
capacity of a Skilled
Nursing Facility resident
assessment.
1395i-3(b)(3)(B)(ii)(2).............. 42 CFR 1003.210(a)(11). OIG............. Penalty for causing another 2016 10,314 10,483
to certify or make a false
statement in assessment of
functional capacity of a
Skilled Nursing Facility
resident assessment.
1395i-3(g)(2)(A)..................... 42 CFR 1003.1310....... OIG............. Penalty for any individual 2016 4,126 4,194
who notifies or causes to
be notified a Skilled
Nursing Facility of the
time or date on which a
survey is to be conducted.
1395w-27(g)(2)(A).................... 42 CFR 1003.410........ OIG............. Penalty for a Medicare 2016 37,561 38,175
Advantage organization
that substantially fails
to provide medically
necessary, required items
and services.
Penalty for a Medicare 2016 36,794 37,396
Advantage organization
that charges excessive
premiums.
Penalty for a Medicare 2016 36,794 37,396
Advantage organization
that improperly expels or
refuses to reenroll a
beneficiary.
Penalty for a Medicare 2016 147,177 149,585
Advantage organization
that engages in practice
that would reasonably be
expected to have the
effect of denying or
discouraging enrollment.
[[Page 9179]]
Penalty per individual who 2016 22,077 22,438
does not enroll as a
result of a Medicare
Advantage organization's
practice that would
reasonably be expected to
have the effect of denying
or discouraging
enrollment.
Penalty for a Medicare 2016 147,177 149,585
Advantage organization
misrepresenting or
falsifying information to
Secretary.
Penalty for a Medicare 2016 36,794 37,396
Advantage organization
misrepresenting or
falsifying information to
individual or other
entity.
Penalty for Medicare 2016 36,794 37,396
Advantage organization
interfering with
provider's advice to
enrollee and non-MCO
affiliated providers that
balance bill enrollees.
Penalty for a Medicare 2016 36,794 37,396
Advantage organization
that employs or contracts
with excluded individual
or entity.
Penalty for a Medicare 2016 36,794 37,396
Advantage organization
enrolling an individual in
without prior written
consent.
Penalty for a Medicare 2016 36,794 37,396
Advantage organization
transferring an enrollee
to another plan without
consent or solely for the
purpose of earning a
commission.
Penalty for a Medicare 2016 36,794 37,396
Advantage organization
failing to comply with
marketing restrictions or
applicable implementing
regulations or guidance.
Penalty for a Medicare 2016 36,794 37,396
Advantage organization
employing or contracting
with an individual or
entity who violates 1395w-
27(g)(1)(A)-(J).
1395w-141(i)(3)...................... ....................... OIG............. Penalty for a prescription 2016 12,856 13,066
drug card sponsor that
falsifies or misrepresents
marketing materials,
overcharges program
enrollees, or misuse
transitional assistance
funds.
1395cc(g)............................ ....................... OIG............. Penalty for improper 2016 5,000 5,082
billing by Hospitals,
Critical Access Hospitals,
or Skilled Nursing
Facilities.
1395dd(d)(1)......................... 42 CFR 1003.510........ OIG............. Penalty for a hospital or 2016 103,139 104,826
responsible physician
dumping patients needing
emergency medical care, if
the hospital has 100 beds
or more.
Penalty for a hospital or 2016 51,570 52,414
responsible physician
dumping patients needing
emergency medical care, if
the hospital has less than
100 beds.
1395mm(i)(6)(B)(i)................... 42 CFR 1003.410........ OIG............. Penalty for a HMO or 2016 51,570 52,414
competitive plan is such
plan substantially fails
to provide medically
necessary, required items
or services.
Penalty for HMOs/ 2016 51,570 52,414
competitive medical plans
that charge premiums in
excess of permitted
amounts.
Penalty for a HMO or 2016 51,570 52,414
competitive medical plan
that expels or refuses to
reenroll an individual per
prescribed conditions.
Penalty for a HMO or 2016 206,278 209,653
competitive medical plan
that implements practices
to discourage enrollment
of individuals needing
services in future.
Penalty per individual not 2016 29,680 30,166
enrolled in a plan as a
result of a HMO or
competitive medical plan
that implements practices
to discourage enrollment
of individuals needing
services in the future.
Penalty for a HMO or 2016 206,278 209,653
competitive medical plan
that misrepresents or
falsifies information to
the Secretary.
Penalty for a HMO or 2016 51,570 52,414
competitive medical plan
that misrepresents or
falsifies information to
an individual or any other
entity.
Penalty for failure by HMO 2016 51,570 52,414
or competitive medical
plan to assure prompt
payment of Medicare risk
sharing contracts or
incentive plan provisions.
Penalty for HMO that 2016 47,340 48,114
employs or contracts with
excluded individual or
entity.
1395nn(g)(3)......................... 42 CFR 1003.310........ OIG............. Penalty for submitting or 2016 23,863 24,253
causing to be submitted
claims in violation of the
Stark Law's restrictions
on physician self-
referrals.
[[Page 9180]]
1395nn(g)(4)......................... 42 CFR 1003.310........ OIG............. Penalty for circumventing 2016 159,089 161,692
Stark Law's restrictions
on physician self-
referrals.
1395ss(d)(1)......................... 42 CFR 1003.1110....... OIG............. Penalty for a material 2016 9,893 10,055
misrepresentation
regarding Medigap
compliance policies.
1395ss(d)(2)......................... 42 CFR 1003.1110....... OIG............. Penalty for selling Medigap 2016 9,893 10,055
policy under false
pretense.
1395ss(d)(3)(A)(ii).................. 42 CFR 1003.1110....... OIG............. Penalty for an issuer that 2016 44,539 45,268
sells health insurance
policy that duplicates
benefits.
Penalty for someone other 2016 26,723 27,160
than issuer that sells
health insurance that
duplicates benefits.
1395ss(d)(4)(A)...................... 42 CFR 1003.1110....... OIG............. Penalty for using mail to 2016 9,893 10,055
sell a non-approved
Medigap insurance policy.
1396b(m)(5)(B)(i).................... 42 CFR 1003.410........ OIG............. Penalty for a Medicaid MCO 2016 49,467 50,276
that substantially fails
to provide medically
necessary, required items
or services.
Penalty for a Medicaid MCO 2016 49,467 50,276
that charges excessive
premiums.
Penalty for a Medicaid MCO 2016 197,869 201,106
that improperly expels or
refuses to reenroll a
beneficiary.
Penalty per individual who 2016 29,680 30,166
does not enroll as a
result of a Medicaid MCO's
practice that would
reasonably be expected to
have the effect of denying
or discouraging
enrollment.
Penalty for a Medicaid MCO 2016 197,869 201,106
misrepresenting or
falsifying information to
the Secretary.
Penalty for a Medicaid MCO 2016 49,467 50,276
misrepresenting or
falsifying information to
an individual or another
entity.
Penalty for a Medicaid MCO 2016 44,539 45,268
that fails to comply with
contract requirements with
respect to physician
incentive plans.
1396r(b)(3)(B)(ii)(I)................ 42 CFR 1003.210(a)(11). OIG............. Penalty for willfully and 2016 2,063 2,097
knowingly certifying a
material and false
statement in a Skilled
Nursing Facility resident
assessment.
1396r(b)(3)(B)(ii)(II)............... 42 CFR 1003.210(a)(11). OIG............. Penalty for willfully and 2016 10,314 10,483
knowingly causing another
individual to certify a
material and false
statement in a Skilled
Nursing Facility resident
assessment.
1396r(g)(2)(A)(i).................... 42 CFR 1003.1310....... OIG............. Penalty for notifying or 2016 4,126 4,194
causing to be notified a
Skilled Nursing Facility
of the time or date on
which a survey is to be
conducted.
1396r-8(b)(3)(B)..................... 42 CFR 1003.1210....... OIG............. Penalty for the knowing 2016 178,156 181,071
provision of false
information or refusing to
provide information about
charges or prices of a
covered outpatient drug.
1396r-8(b)(3)(C)(i).................. 42 CFR 1003.1210....... OIG............. Penalty per day for failure 2016 17,816 18,107
to timely provide
information by drug
manufacturer with rebate
agreement.
1396r-8(b)(3)(C)(ii)................. 42 CFR 1003.1210....... OIG............. Penalty for knowing 2016 178,156 181,071
provision of false
information by drug
manufacturer with rebate
agreement.
1396t(i)(3)(A)....................... 42 CFR 1003.1310....... OIG............. Penalty for notifying home 2016 3,563 3,621
and community-based
providers or settings of
survey.
11131(c)............................. 42 CFR 1003.810........ OIG............. Penalty for failing to 2016 21,563 21,916
report a medical
malpractice claim to
National Practitioner Data
Bank.
11137(b)(2).......................... 42 CFR 1003.810........ OIG............. Penalty for breaching 2016 21,563 21,916
confidentiality of
information reported to
National Practitioner Data
Bank.
299b-22(f)(1)........................ 42 CFR 3.404........... OCR............. Penalty for violation of 2016 11,940 12,135
confidentiality provision
of the Patient Safety and
Quality Improvement Act.
45 CFR OCR............. Penalty for each pre- 2016 150 152
160.404(b)(1)(i), (ii) February 18, 2009
violation of the HIPAA
administrative
simplification provisions.
Calendar Year Cap.......... 2016 37,561 38,175
1320(d)-5(a)......................... 45 CFR OCR............. Penalty for each February
160.404(b)(2)(i)(A), 18, 2009 or later
(B). violation of a HIPAA
administrative
simplification provision
in which it is established
that the covered entity or
business associate did not
know and by exercising
reasonable diligence,
would not have known that
the covered entity or
business associate
violated such a provision:
Minimum.................... 2016 110 112
Maximum.................... 2016 55,010 55,910
Calendar Year Cap.......... 2016 1,650,300 1,677,299
[[Page 9181]]
45 CFR OCR............. Penalty for each February
160.404(b)(2)(ii)(A), 18, 2009 or later
(B) violation of a HIPAA
administrative
simplification provision
in which it is established
that the violation was due
to reasonable cause and
not to willful neglect:
Minimum.................... 2016 1,100 1,118
Maximum.................... 2016 55,010 55,910
Calendar Year Cap.......... 2016 1,650,300 1,677,299
45 CFR OCR............. Penalty for each February
160.404(b)(2)(iii)(A), 18, 2009 or later
(B) violation of a HIPAA
administrative
simplification provision
in which it is established
that the violation was due
to willful neglect and was
corrected during the 30-
day period beginning on
the first date the covered
entity or business
associate knew, or, by
exercising reasonable
diligence, would have
known that the violation
occurred:
Minimum.................... 2016 11,002 11,182
Maximum.................... 2016 55,010 55,910
Calendar Year Cap.......... 2016 1,650,300 1,677,299
45 CFR OCR............. Penalty for each February
160.404(b)(2)(iv)(A), 18, 2009 or later
(B) violation of a HIPAA
administrative
simplification provision
in which it is established
that the violation was due
to willful neglect and was
not corrected during the
30-day period beginning on
the first date the covered
entity or business
associate knew, or by
exercising reasonable
diligence, would have
known that the violation
occurred:
Minimum.................... 2016 55,010 55,910
Maximum.................... 2016 1,650,300 1,677,299
Calendar Year Cap.......... 2016 1,650,300 1,677,299
263a(h)(2)(B) & 1395w-2(b)(2)(A)(ii). 42 CFR CMS............. Penalty for a clinical
493.1834(d)(2)(i). laboratory's failure to
meet participation and
certification requirements
and poses immediate
jeopardy:
Minimum.................... 2016 6,035 6,134
Maximum.................... 2016 19,787 20,111
42 CFR CMS............. Penalty for a clinical
493.1834(d)(2)(ii). laboratory's failure to
meet participation and
certification requirements
and the failure does not
pose immediate jeopardy:
Minimum.................... 2016 99 101
Maximum.................... 2016 5,936 6,033
300gg-15(f).......................... 45 CFR 147.200(e)...... CMS............. Failure to provide the 2016 1,087 1,105
Summary of Benefits and
Coverage.
300gg-18............................. 45 CFR 158.606......... CMS............. Penalty for violations of 2016 109 111
regulations related to the
medical loss ratio
reporting and rebating.
1320a-7h(b)(1)....................... 42 CFR 402.105(d)(5), CMS............. Penalty for manufacturer or
42 CFR 403.912(a) & group purchasing
(c). organization failing to
report information
required under 42 U.S.C.
1320a-7h(a), relating to
physician ownership or
investment interests:
Minimum.................... 2016 1,087 1,105
Maximum.................... 2016 10,874 11,052
Calendar Year Cap.......... 2016 163,117 165,786
1320a-7h(b)(2)....................... 42 CFR 402.105(h), 42 CMS............. Penalty for manufacturer or
CFR 403.912(b) & (c). group purchasing
organization knowingly
failing to report
information required under
42 U.S.C. 1320a-7h(a),
relating to physician
ownership or investment
interests:
Minimum.................... 2016 10,874 11,052
Maximum.................... 2016 108,745 110,524
Calendar Year Cap.......... 2016 1,087,450 1,105,241
CMS Penalty for an 2016 108,745 110,524
administrator of a
facility that fails to
comply with notice
requirements for the
closure of a facility.
1320a-7j(h)(3)(A).................... 42 CFR 488.446(a)(1), CMS............. Minimum penalty for the 2016 544 553
(2), & (3). first offense of an
administrator who fails to
provide notice of facility
closure.
Minimum penalty for the 2016 1,631 1,658
second offense of an
administrator who fails to
provide notice of facility
closure.
Minimum penalty for the 2016 3,262 3,315
third and subsequent
offenses of an
administrator who fails to
provide notice of facility
closure.
[[Page 9182]]
1320a-8(a)(1)........................ ....................... CMS............. Penalty for an entity 2016 7,954 8,084
knowingly making a false
statement or
representation of material
fact in the determination
of the amount of benefits
or payments related to old-
age, survivors, and
disability insurance
benefits, special benefits
for certain World War II
veterans, or supplemental
security income for the
aged, blind, and disabled.
Penalty for violation of 42 2016 7,500 7,623
U.S.C. 1320a-8(a)(1) if
the violator is a person
who receives a fee or
other income for services
performed in connection
with determination of the
benefit amount or the
person is a physician or
other health care provider
who submits evidence in
connection with such a
determination.
1320a-8(a)(3)........................ ....................... CMS............. Penalty for a 2016 6,229 6,331
representative payee
(under 42 U.S.C. 405(j),
1007, or 1383(a)(2))
converting any part of a
received payment from the
benefit programs described
in the previous civil
monetary penalty to a use
other than for the benefit
of the beneficiary.
1320b-25(c)(1)(A).................... ....................... CMS............. Penalty for failure of 2016 217,490 221,048
covered individuals to
report to the Secretary
and 1 or more law
enforcement officials any
reasonable suspicion of a
crime against a resident,
or individual receiving
care, from a long-term
care facility.
1320b-25(c)(2)(A).................... ....................... CMS............. Penalty for failure of 2016 326,235 331,572
covered individuals to
report to the Secretary
and 1 or more law
enforcement officials any
reasonable suspicion of a
crime against a resident,
or individual receiving
care, from a long-term
care facility if such
failure exacerbates the
harm to the victim of the
crime or results in the
harm to another individual.
1320b-25(d)(2)....................... ....................... CMS............. Penalty for a long-term 2016 217,490 221,048
care facility that
retaliates against any
employee because of lawful
acts done by the employee,
or files a complaint or
report with the State
professional disciplinary
agency against an employee
or nurse for lawful acts
done by the employee or
nurse.
1395b-7(b)(2)(B)..................... 42 CFR 402.105(g)...... CMS............. Penalty for any person who 2016 147 149
knowingly and willfully
fails to furnish a
beneficiary with an
itemized statement of
items or services within
30 days of the
beneficiary's request.
1395i-3(h)(2)(B)(ii)(I).............. 42 CFR CMS............. Penalty per day for a
488.408(d)(1)(iii). Skilled Nursing Facility
that has a Category 2
violation of certification
requirements:
Minimum.................... 2016 103 105
Maximum.................... 2016 6,188 6,289
42 CFR CMS............. Penalty per instance of
488.408(d)(1)(iv) Category 2 noncompliance
by a Skilled Nursing
Facility:
Minimum.................... 2016 2,063 2,097
Maximum.................... 2016 20,628 20,965
42 CFR CMS............. Penalty per day for a
488.408(e)(1)(iii) Skilled Nursing Facility
that has a Category 3
violation of certification
requirements:
Minimum.................... 2016 6,291 6,394
Maximum.................... 2016 20,628 20,965
42 CFR CMS............. Penalty per instance of
488.408(e)(1)(iv) Category 3 noncompliance
by a Skilled Nursing
Facility:
Minimum.................... 2016 2,063 2,097
Maximum.................... 2016 20,628 20,965
42 CFR CMS............. Penalty per day and per
488.408(e)(2)(ii) instance for a Skilled
Nursing Facility that has
Category 3 noncompliance
with Immediate Jeopardy:
Per Day (Minimum).......... 2016 6,291 6,394
Per Day (Maximum).......... 2016 20,628 20,965
Per Instance (Minimum)..... 2016 2,063 2,097
Per Instance (Maximum)..... 2016 20,628 20,965
42 CFR 488.438(a)(1)(i) CMS............. Penalty per day of a
Skilled Nursing Facility
that fails to meet
certification
requirements. These
amounts represent the
upper range per day:
Minimum.................... 2016 6,291 6,394
Maximum.................... 2016 20,628 20,965
42 CFR CMS............. Penalty per day of a
488.438(a)(1)(ii) Skilled Nursing Facility
that fails to meet
certification
requirements. These
amounts represent the
lower range per day:
[[Page 9183]]
Minimum.................... 2016 103 105
Maximum.................... 2016 6,188 6,289
42 CFR 488.438(a)(2) CMS............. Penalty per instance of a
Skilled Nursing Facility
that fails to meet
certification
requirements:
Minimum.................... 2016 2,063 2,097
Maximum.................... 2016 20,628 20,965
1395l(h)(5)(D)....................... 42 CFR 402.105(d)(2)(i) CMS............. Penalty for knowingly, 2016 15,024 15,270
willfully, and repeatedly
billing for a clinical
diagnostic laboratory test
other than on an
assignment-related basis.
(Penalties are assessed in
the same manner as 42
U.S.C. 1395u(j)(2)(B),
which is assessed
according to 1320a-7a(a)).
1395l(i)(6).......................... ....................... CMS............. Penalty for knowingly and 2016 3,957 4,022
willfully presenting or
causing to be presented a
bill or request for
payment for an intraocular
lens inserted during or
after cataract surgery for
which the Medicare payment
rate includes the cost of
acquiring the class of
lens involved.
1395l(q)(2)(B)(i).................... 42 CFR 402.105(a)...... CMS............. Penalty for knowingly and 2016 3,787 3,849
willfully failing to
provide information about
a referring physician when
seeking payment on an
unassigned basis.
1395m(a)(11)(A)...................... 42 CFR 402.1(c)(4), CMS............. Penalty for any durable 2016 15,024 15,270
402.105(d)(2)(ii). medical equipment supplier
that knowingly and
willfully charges for a
covered service that is
furnished on a rental
basis after the rental
payments may no longer be
made. (Penalties are
assessed in the same
manner as 42 U.S.C.
1395u(j)(2)(B), which is
assessed according to
1320a-7a(a)).
1395m(a)(18)(B)...................... 42 CFR 402.1(c)(5), CMS............. Penalty for any 2016 15,024 15,270
402.105(d)(2)(iii). nonparticipating durable
medical equipment supplier
that knowingly and
willfully fails to make a
refund to Medicare
beneficiaries for a
covered service for which
payment is precluded due
to an unsolicited
telephone contact from the
supplier. (Penalties are
assessed in the same
manner as 42 U.S.C.
1395u(j)(2)(B), which is
assessed according to
1320a-7a(a)).
1395m(b)(5)(C)....................... 42 CFR 402.1(c)(6), CMS............. Penalty for any 2016 15,024 15,270
402.105(d)(2)(iv). nonparticipating physician
or supplier that knowingly
and willfully charges a
Medicare beneficiary more
than the limiting charge
for radiologist services.
(Penalties are assessed in
the same manner as 42
U.S.C. 1395u(j)(2)(B),
which is assessed
according to 1320a-7a(a)).
1395m(h)(3).......................... 42 CFR 402.1(c)(8), CMS............. Penalty for any supplier of 2016 15,024 15,270
402.105(d)(2)(vi). prosthetic devices,
orthotics, and prosthetics
that knowing and willfully
charges for a covered
prosthetic device,
orthotic, or prosthetic
that is furnished on a
rental basis after the
rental payment may no
longer be made. (Penalties
are assessed in the same
manner as 42 U.S.C.
1395m(a)(11)(A), that is
in the same manner as
1395u(j)(2)(B), which is
assessed according to
1320a-7a(a)).
1395m(j)(2)(A)(iii).................. ....................... CMS............. Penalty for any supplier of 2016 1,591 1,617
durable medical equipment
including a supplier of
prosthetic devices,
prosthetics, orthotics, or
supplies that knowingly
and willfully distributes
a certificate of medical
necessity in violation of
Section 1834(j)(2)(A)(i)
of the Act or fails to
provide the information
required under Section
1834(j)(2)(A)(ii) of the
Act.
1395m(j)(4).......................... 42 CFR 402.1(c)(10), CMS............. Penalty for any supplier of 2016 15,024 15,270
402.105(d)(2)(vii). durable medical equipment,
including a supplier of
prosthetic devices,
prosthetics, orthotics, or
supplies that knowingly
and willfully fails to
make refunds in a timely
manner to Medicare
beneficiaries for series
billed other than on as
assignment-related basis
under certain conditions.
(Penalties are assessed in
the same manner as 42
U.S.C. 1395m(j)(4) and
1395u(j)(2)(B), which is
assessed according to
1320a-7a(a)).
[[Page 9184]]
1395m(k)(6).......................... 42 CFR 402.1(c)(31), CMS............. Penalty for any person or 2016 15,024 15,270
402.105(d)(3). entity who knowingly and
willfully bills or
collects for any
outpatient therapy
services or comprehensive
outpatient rehabilitation
services on other than an
assignment-related basis.
(Penalties are assessed in
the same manner as 42
U.S.C. 1395m(k)(6) and
1395u(j)(2)(B), which is
assessed according to
1320a-7a(a)).
1395m(l)(6).......................... 42 CFR 402.1(c)(32), CMS............. Penalty for any supplier of 2016 15,024 15,270
402.105(d)(4). ambulance services who
knowingly and willfully
fills or collects for any
services on other than an
assignment-related basis.
(Penalties are assessed in
the same manner as 42
U.S.C. 1395u(b)(18)(B),
which is assessed
according to 1320a-7a(a)).
1395u(b)(18)(B)...................... 42 CFR 402.1(c)(11), CMS............. Penalty for any 2016 15,024 15,270
402.105(d)(2)(viii). practitioner specified in
Section 1842(b)(18)(C) of
the Act or other person
that knowingly and
willfully bills or
collects for any services
by the practitioners on
other than an assignment-
related basis. (Penalties
are assessed in the same
manner as 42 U.S.C.
1395u(j)(2)(B), which is
assessed according to
1320a-7a(a)).
1395u(j)(2)(B)....................... 42 CFR 402.1(c)........ CMS............. Penalty for any physician 2016 15,024 15,270
who charges more than 125%
for a non-participating
referral. (Penalties are
assessed in the same
manner as 42 U.S.C. 1320a-
7a(a)).
1395u(k)............................. 42 CFR 402.1(c)(12), CMS............. Penalty for any physician 2016 15,024 15,270
402.105(d)(2)(ix). who knowingly and
willfully presents or
causes to be presented a
claim for bill for an
assistant at a cataract
surgery performed on or
after March 1, 1987, for
which payment may not be
made because of section
1862(a)(15). (Penalties
are assessed in the same
manner as 42 U.S.C.
1395u(j)(2)(B), which is
assessed according to
1320a-7a(a)).
1395u(l)(3).......................... 42 CFR 402.1(c)(13), CMS............. Penalty for any 2016 15,024 15,270
402.105(d)(2)(x). nonparticipating physician
who does not accept
payment on an assignment-
related basis and who
knowingly and willfully
fails to refund on a
timely basis any amounts
collected for services
that are not reasonable or
medically necessary or are
of poor quality under
1842(l)(1)(A). (Penalties
are assessed in the same
manner as 42 U.S.C.
1395u(j)(2)(B), which is
assessed according to
1320a-7a(a)).
1395u(m)(3).......................... 42 CFR 402.1(c)(14), CMS............. Penalty for any 2016 15,024 15,270
402.105(d)(2)(xi). nonparticipating physician
charging more than $500
who does not accept
payment for an elective
surgical procedure on an
assignment related basis
and who knowingly and
willfully fails to
disclose the required
information regarding
charges and coinsurance
amounts and fails to
refund on a timely basis
any amount collected for
the procedure in excess of
the charges recognized and
approved by the Medicare
program. (Penalties are
assessed in the same
manner as 42 U.S.C.
1395u(j)(2)(B), which is
assessed according to
1320a-7a(a)).
1395u(n)(3).......................... 42 CFR 402.1(c)(15), CMS............. Penalty for any physician 2016 15,024 15,270
402.105(d)(2)(xii). who knowingly, willfully,
and repeatedly bills one
or more beneficiaries for
purchased diagnostic tests
any amount other than the
payment amount specified
by the Act. (Penalties are
assessed in the same
manner as 42 U.S.C.
1395u(j)(2)(B), which is
assessed according to
1320a-7a(a)).
1395u(o)(3)(B)....................... 42 CFR 414.707(b)...... CMS............. Penalty for any 2016 15,024 15,270
practitioner specified in
Section 1842(b)(18)(C) of
the Act or other person
that knowingly and
willfully bills or
collects for any services
pertaining to drugs or
biologics by the
practitioners on other
than an assignment-related
basis. (Penalties are
assessed in the same
manner as 42 U.S.C.
1395u(b)(18)(B) and
1395u(j)(2)(B), which is
assessed according to
1320a-7a(a)).
[[Page 9185]]
1395u(p)(3)(A)....................... ....................... CMS............. Penalty for any physician 2016 3,957 4,022
or practitioner who
knowingly and willfully
fails promptly to provide
the appropriate diagnosis
codes upon CMS or Medicare
administrative contractor
request for payment or
bill not submitted on an
assignment-related basis.
1395w-3a(d)(4)(A).................... 42 CFR 414.806......... CMS............. Penalty for a 2016 12,856 13,066
pharmaceutical
manufacturer's
misrepresentation of
average sales price of a
drug, or biologic.
1395w-4(g)(1)(B)..................... 42 CFR 402.1(c)(17), CMS............. Penalty for any 2016 15,024 15,270
402.105(d)(2)(xiii). nonparticipating
physician, supplier, or
other person that
furnishes physician
services not on an
assignment-related basis
who either knowingly and
willfully bills or
collects in excess of the
statutorily-defined
limiting charge or fails
to make a timely refund or
adjustment. (Penalties are
assessed in the same
manner as 42 U.S.C.
1395u(j)(2)(B), which is
assessed according to
1320a-7a(a)).
1395w-4(g)(3)(B)..................... 42 CFR 402.1(c)(18), CMS............. Penalty for any person that 2016 15,024 15,270
402.105(d)(2)(xiv). knowingly and willfully
bills for statutorily
defined State-plan
approved physicians'
services on any other
basis than an assignment-
related basis for a
Medicare/Medicaid dual
eligible beneficiary.
(Penalties are assessed in
the same manner as 42
U.S.C. 1395u(j)(2)(B),
which is assessed
according to 1320a-7a(a)).
1395w-27(g)(3)(A); 1857(g)(3)........ 42 CFR 422.760(b); 42 CMS............. Penalty for each 2016 36,794 37,396
CFR 423.760(b). termination determination
the Secretary makes that
is the result of actions
by a Medicare Advantage
organization or Part D
sponsor that has adversely
affected an individual
covered under the
organization's contract.
1395w-27(g)(3)(B); 1857(g)(3)........ ....................... CMS............. Penalty for each week 2016 14,718 14,959
beginning after the
initiation of civil money
penalty procedures by the
Secretary because a
Medicare Advantage
organization or Part D
sponsor has failed to
carry out a contract, or
has carried out a contract
inconsistently with
regulations.
1395w-27(g)(3)(D); 1857(g)(3)........ ....................... CMS............. Penalty for a Medicare 2016 136,689 138,925
Advantage organization's
or Part D sponsor's early
termination of its
contract.
1395y(b)(3)(C)....................... 42 CFR 411.103(b)...... CMS............. Penalty for an employer or 2016 8,908 9,054
other entity to offer any
financial or other
incentive for an
individual entitled to
benefits not to enroll
under a group health plan
or large group health plan
which would be a primary
plan.
1395y(b)(5)(C)(ii)................... 42 CFR 402.1(c)(20), 42 CMS............. Penalty for any non- 2016 1,450 1,474
CFR 402.105(b)(2). governmental employer
that, before October 1,
1998, willfully or
repeatedly failed to
provide timely and
accurate information
requested relating to an
employee's group health
insurance coverage.
1395y(b)(6)(B)....................... 42 CFR 402.1(c)(21), CMS............. Penalty for any entity that 2016 3,182 3,234
402.105(a). knowingly, willfully, and
repeatedly fails to
complete a claim form
relating to the
availability of other
health benefits in
accordance with statute or
provides inaccurate
information relating to
such on the claim form.
1395y(b)(7)(B)(i).................... ....................... CMS............. Penalty for any entity 2016 1,138 1,157
serving as insurer, third
party administrator, or
fiduciary for a group
health plan that fails to
provide information that
identifies situations
where the group health
plan is or was a primary
plan to Medicare to the
HHS Secretary.
1395y(b)(8)(E)....................... ....................... CMS............. Penalty for any non-group 2016 1,138 1,157
health plan that fails to
identify claimants who are
Medicare beneficiaries and
provide information to the
HHS Secretary to
coordinate benefits and
pursue any applicable
recovery claim.
1395nn(g)(5)......................... 42 CFR 411.361......... CMS............. Penalty for any person that 2016 18,936 19,246
fails to report
information required by
HHS under Section 1877(f)
concerning ownership,
investment, and
compensation arrangements.
[[Page 9186]]
1395pp(h)............................ 42 CFR 402.1(c)(23), CMS............. Penalty for any durable 2016 15,024 15,270
402.105(d)(2)(xv). medical equipment
supplier, including a
supplier of prosthetic
devices, prosthetics,
orthotics, or supplies,
that knowingly and
willfully fails to make
refunds in a timely manner
to Medicare beneficiaries
under certain conditions.
(42 U.S.C. 1395(m)(18)
sanctions apply here in
the same manner, which is
under 1395u(j)(2) and
1320a-7a(a)).
1395ss(a)(2)......................... 42 CFR 402.1(c)(24), CMS............. Penalty for any person that 2016 51,569 52,413
405.105(f)(1). issues a Medicare
supplemental policy that
has not been approved by
the State regulatory
program or does not meet
Federal standards after a
statutorily defined
effective date.
1395ss(d)(3)(A)(vi) (II)............. ....................... CMS............. Penalty for someone other 2016 26,723 27,160
than issuer that sells or
issues a Medicare
supplemental policy to
beneficiary without a
disclosure statement.
Penalty for an issuer that 2016 44,539 45,268
sells or issues a Medicare
supplemental policy
without disclosure
statement.
1395ss(d)(3)(B)(iv).................. ....................... CMS............. Penalty for someone other 2016 26,723 27,160
than issuer that sells or
issues a Medicare
supplemental policy
without acknowledgement
form.
Penalty for issuer that 2016 44,539 45,268
sells or issues a Medicare
supplemental policy
without an acknowledgement
form.
1395ss(p)(8)......................... 42 CFR 402.1(c)(25), CMS............. Penalty for any person that 2016 26,723 27,160
402.105(e). sells or issues Medicare
supplemental polices after
a given date that fail to
conform to the NAIC or
Federal standards
established by statute.
42 CFR 402.1(c)(25), CMS............. Penalty for any person that 2016 44,539 45,268
405.105(f)(2) sells or issues Medicare
supplemental polices after
a given date that fail to
conform to the NAIC or
Federal standards
established by statute.
1395ss(p)(9)(C)...................... 42 CFR 402.1(c)(26), CMS............. Penalty for any person that 2016 26,723 27,160
402.105(e). sells a Medicare
supplemental policy and
fails to make available
for sale the core group of
basic benefits when
selling other Medicare
supplemental policies with
additional benefits or
fails to provide the
individual, before selling
the policy, an outline of
coverage describing
benefits.
42 CFR 402.1(c)(26), ................ Penalty for any person that 2016 44,539 45,268
405.105(f)(3), (4) sells a Medicare
supplemental policy and
fails to make available
for sale the core group of
basic benefits when
selling other Medicare
supplemental policies with
additional benefits or
fails to provide the
individual, before selling
the policy, an outline of
coverage describing
benefits.
1395ss(q)(5)(C)...................... 42 CFR 402.1(c)(27), CMS............. Penalty for any person that 2016 44,539 45,268
405.105(f)(5). fails to suspend the
policy of a policyholder
made eligible for medical
assistance or
automatically reinstates
the policy of a
policyholder who has lost
eligibility for medical
assistance, under certain
circumstances.
1395ss(r)(6)(A)...................... 42 CFR 402.1(c)(28), CMS............. Penalty for any person that 2016 44,539 45,268
405.105(f)(6). fails to provide refunds
or credits as required by
section 1882(r)(1)(B).
1395ss(s)(4)......................... 42 CFR 402.1(c)(29), CMS............. Penalty for any issuer of a 2016 18,908 19,217
405.105(c). Medicare supplemental
policy that does not waive
listed time periods if
they were already
satisfied under a
proceeding Medicare
supplemental policy, or
denies a policy, or
conditions the issuances
or effectiveness of the
policy, or discriminates
in the pricing of the
policy base on health
status or other specified
criteria.
1395ss(t)(2)......................... 42 CFR 402.1(c)(30), CMS............. Penalty for any issuer of a 2016 44,539 45,268
405.105(f)(7). Medicare supplemental
policy that fails to
fulfill listed
responsibilities.
1395ss(v)(4)(A)...................... ....................... CMS............. Penalty someone other than 2016 19,284 19,599
issuer who sells, issues,
or renews a medigap Rx
policy to an individual
who is a Part D enrollee.
Penalty for an issuer who 2016 32,140 32,666
sells, issues, or renews a
Medigap Rx policy who is a
Part D enrollee.
1395bbb(c)(1)........................ 42 CFR 488.725(c)...... CMS............. Penalty for any individual 2016 4,126 4,194
who notifies or causes to
be notified a home health
agency of the time or date
on which a survey of such
agency is to be conducted.
[[Page 9187]]
1395bbb(f)(2)(A)(i).................. 42 CFR CMS............. Maximum daily penalty 2016 19,787 20,111
488.845(b)(2)(iii) 42 amount for each day a home
CFR 488.845(b)(3)-(6); health agency is not in
and 42 CFR compliance with statutory
488.845(d)(1)(ii). requirements.
42 CFR 488.845(b)(3) ................ Penalty per day for home
health agency's
noncompliance (Upper
Range):
Minimum.................... 2016 16,819 17,094
Maximum.................... 2016 19,787 20,111
42 CFR 488.845(b)(3)(i) ................ Penalty for a home health 2016 19,787 20,111
agency's deficiency or
deficiencies that cause
immediate jeopardy and
result in actual harm.
42 CFR ................ Penalty for a home health 2016 17,808 18,099
488.845(b)(3)(ii) agency's deficiency or
deficiencies that cause
immediate jeopardy and
result in potential for
harm.
42 CFR ................ Penalty for an isolated 2016 16,819 17,094
488.845(b)(3)(iii) incident of noncompliance
in violation of
established HHA policy.
42 CFR 488.845(b)(4) ................ Penalty for a repeat and/or
condition-level deficiency
that does not constitute
immediate jeopardy, but is
directly related to poor
quality patient care
outcomes (Lower Range):
Minimum.................... 2016 2,968 3,017
Maximum.................... 2016 16,819 17,094
42 CFR 488.845(b)(5) ................ Penalty for a repeat and/or
condition-level deficiency
that does not constitute
immediate jeopardy and
that is related
predominately to structure
or process-oriented
conditions (Lower Range):
Minimum.................... 2016 989 1,005
Maximum.................... 2016 7,915 8,044
42 CFR 488.845(b)(6) ................ Penalty imposed for
instance of noncompliance
that may be assessed for
one or more singular
events of condition-level
noncompliance that are
identified and where the
noncompliance was
corrected during the
onsite survey:
Minimum.................... 2016 1,979 2,011
Maximum.................... 2016 19,787 20,111
Penalty for each day of 2016 19,787 20,111
noncompliance (Maximum).
42 CFR ................ Penalty for each day of 2016 19,787 20,111
488.845(d)(1)(ii) noncompliance (Maximum).
1396b(m)(5)(B)....................... 42 CFR 460.46.......... CMS............. Penalty for PACE
organization's practice
that would reasonably be
expected to have the
effect of denying or
discouraging enrollment:
Minimum.................... 2016 22,077 22,438
Maximum.................... 2016 147,177 149,585
Penalty for a PACE 2016 36,794 37,396
organization that charges
excessive premiums.
Penalty for a PACE 2016 147,177 149,585
organization
misrepresenting or
falsifying information to
CMS, the State, or an
individual or other
entity.
Penalty for each 2016 36,794 37,396
determination the CMS
makes that the PACE
organization has failed to
provide medically
necessary items and
services of the failure
has adversely affected (or
has the substantial
likelihood of adversely
affecting) a PACE
participant.
Penalty for involuntarily 2016 36,794 37,396
disenrolling a
participant.
Penalty for discriminating 2016 36,794 37,396
or discouraging enrollment
or disenrollment of
participants on the basis
of an individual's health
status or need for health
care services.
1396r(h)(3)(C)(ii)(I)................ 42 CFR CMS............. Penalty per day for a
488.408(d)(1)(iii). nursing facility's failure
to meet a Category 2
Certification:
Minimum.................... 2016 103 105
Maximum.................... 2016 6,188 6,289
42 CFR CMS............. Penalty per instance for a
488.408(d)(1)(iv) nursing facility's failure
to meet Category 2
certification:
Minimum.................... 2016 2,063 2,097
Maximum.................... 2016 20,628 20,965
42 CFR CMS............. Penalty per day for a
488.408(e)(1)(iii) nursing facility's failure
to meet Category 3
certification:
Minimum.................... 2016 6,291 6,394
Maximum.................... 2016 20,628 20,965
42 CFR CMS............. Penalty per instance for a
488.408(e)(1)(iv) nursing facility's failure
to meet Category 3
certification:
Minimum.................... 2016 2,063 2,097
[[Page 9188]]
Maximum.................... 2016 20,628 20,965
42 CFR CMS............. Penalty per instance for a
488.408(e)(2)(ii) nursing facility's failure
to meet Category 3
certification, which
results in immediate
jeopardy:
Minimum.................... 2016 2,063 2,097
Maximum.................... 2016 20,628 20,965
42 CFR 488.438(a)(1)(i) CMS............. Penalty per day for nursing
facility's failure to meet
certification (Upper
Range):
Minimum.................... 2016 6,291 6,394
Maximum.................... 2016 20,628 20,965
42 CFR CMS............. Penalty per day for nursing
488.438(a)(1)(ii) facility's failure to meet
certification (Lower
Range):
Minimum.................... 2016 103 105
Maximum.................... 2016 6,188 6,289
42 CFR 488.438(a)(2) CMS............. Penalty per instance for
nursing facility's failure
to meet certification:
Minimum.................... 2016 2,063 2,097
Maximum.................... 2016 20,628 20,965
1396r(f)(2)(B)(iii)(I)(c)............ 42 CFR CMS............. Grounds to prohibit 2016 10,314 10,483
483.151(b)(2)(iv) and approval of Nurse Aide
(b)(3)(iii). Training Program--if
assessed a penalty in
1819(h)(2)(B)(i) or
1919(h)(2)(A)(ii) of ``not
less than $5,000'' [Not
CMP authority, but a
specific CMP amount (CMP
at this level) that is the
triggering condition for
disapproval].
1396r(h)(3)(C)(ii)(I)................ 42 CFR 483.151(c)(2)... CMS............. Grounds to waive 2016 10,314 10,483
disapproval of nurse aide
training program--
reference to disapproval
based on imposition of CMP
``not less than $5,000''
[Not CMP authority but CMP
imposition at this level
determines eligibility to
seek waiver of disapproval
of nurse aide training
program].
1396t(j)(2)(C)....................... ....................... CMS............. Penalty for each day of
noncompliance for a home
or community care provider
that no longer meets the
minimum requirements for
home and community care:
Minimum.................... 2016 2 2
Maximum.................... 2016 17,816 18,107
1396u-2(e)(2)(A)(i).................. 42 CFR 438.704......... CMS............. Penalty for a Medicaid 2016 36,794 37,396
managed care organization
that fails substantially
to provide medically
necessary items and
services.
Penalty for Medicaid 2016 36,794 37,396
managed care organization
that imposes premiums or
charges on enrollees in
excess of the premiums or
charges permitted.
Penalty for a Medicaid 2016 36,794 37,396
managed care organization
that misrepresents or
falsifies information to
another individual or
entity.
Penalty for a Medicaid 2016 36,794 37,396
managed care organization
that fails to comply with
the applicable statutory
requirements for such
organizations.
1396u-2(e)(2)(A)(ii)................. 42 CFR 438.704......... CMS............. Penalty for a Medicaid 2016 147,177 149,585
managed care organization
that misrepresents or
falsifies information to
the HHS Secretary.
Penalty for Medicaid 2016 147,177 149,585
managed care organization
that acts to discriminate
among enrollees on the
basis of their health
status.
1396u-2(e)(2)(A)(iv)................. 42 CFR 438.704......... CMS............. Penalty for each individual 2016 22,077 22,438
that does not enroll as a
result of a Medicaid
managed care organization
that acts to discriminate
among enrollees on the
basis of their health
status.
1396u(h)(2).......................... 42 CFR Part 441, CMS............. Penalty for a provider not 2016 20,628 20,965
Subpart I. meeting one of the
requirements relating to
the protection of the
health, safety, and
welfare of individuals
receiving community
supported living
arrangements services.
1396w-2(c)(1)........................ ....................... CMS............. Penalty for disclosing 2016 11,002 11,182
information related to
eligibility determinations
for medical assistance
programs.
18041(c)(2).......................... 45 CFR 150.315; 45 CFR CMS............. Failure to comply with 2016 150 152
156.805(c). requirements of the Public
Health Services Act;
Penalty for violations of
rules or standards of
behavior associated with
issuer participation in
the Federally-facilitated
Exchange. (42 U.S.C. 300gg-
22(b)(2)(C)).
18081(h)(1)(A)(i)(II)................ 42 CFR 155.285......... CMS............. Penalty for providing false 2016 27,186 27,631
information on Exchange
application.
18081(h)(1)(B)....................... 42 CFR 155.285......... CMS............. Penalty for knowingly or 2016 271,862 276,310
willfully providing false
information on Exchange
application.
[[Page 9189]]
18081(h)(2).......................... 42 CFR 155.260......... CMS............. Penalty for knowingly or 2016 27,186 27,631
willfully disclosing
protected information from
Exchange.
31 U.S.C.
1352................................. 45 CFR 93.400(e)....... HHS............. Penalty for the first time 2016 18,936 19,246
an individual makes an
expenditure prohibited by
regulations regarding
lobbying disclosure,
absent aggravating
circumstances.
Penalty for second and
subsequent offenses by
individuals who make an
expenditure prohibited by
regulations regarding
lobbying disclosure:
Minimum.................... 2016 18,936 19,246
Maximum.................... 2016 189,361 192,459
Penalty for the first time 2016 18,936 19,246
an individual fails to
file or amend a lobbying
disclosure form, absent
aggravating circumstances.
Penalty for second and
subsequent offenses by
individuals who fail to
file or amend a lobbying
disclosure form, absent
aggravating circumstances:
Minimum.................... 2016 18,936 19,246
Maximum.................... 2016 189,361 192,459
45 CFR Part 93, HHS............. Penalty for failure to
Appendix A provide certification
regarding lobbying in the
award documents for all
sub-awards of all tiers:
Minimum.................... 2016 18,936 19,246
Maximum.................... 2016 189,361 192,459
Penalty for failure to
provide statement
regarding lobbying for
loan guarantee and loan
insurance transactions:
Minimum.................... 2016 18,936 19,246
Maximum.................... 2016 189,361 192,459
3801-3812............................ 45 CFR 79.3(a)(1)(iv).. HHS............. Penalty against any 2016 9,894 10,056
individual who--with
knowledge or reason to
know--makes, presents or
submits a false,
fictitious or fraudulent
claim to the Department.
45 CFR 79.3(b)(1)(ii) ................ Penalty against any 2016 9,894 10,056
individual who--with
knowledge or reason to
know--makes, presents or
submits a false,
fictitious or fraudulent
claim to the Department.
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ Some HHS components have not promulgated regulations regarding their civil monetary penalty-specific statutory authorities.
\2\ The description is not intended to be a comprehensive explanation of the underlying violation; the statute and corresponding regulation, if
applicable should be consulted.
\3\ Statutory or Inflation Act Adjustment.
\4\ The cost of living multiplier for 2017, based on the Consumer Price Index (CPI-U) for the month of October 2016, not seasonally adjusted, is
1.01636, as indicated in OMB Memorandum M-17-11, ``Implementation of the 2017 annual adjustment pursuant to the Federal Civil Penalties Adjustment Act
Improvements Act of 2015'' (December 16, 2016).
Dated: January 30, 2017.
Norris Cochran,
Acting Secretary, Department of Health and Human Services.
[FR Doc. 2017-02300 Filed 2-2-17; 8:45 am]
BILLING CODE 4150-24-P